LCD L40276: Non-invasive Arterial Duplex Ultrasound of the Upper and Lower Extremities

Covered Indications

Non-invasive arterial DUS studies are used to diagnose vascular conditions, guide treatment decisions, and monitor surgical intervention effectiveness. DUS arterial studies are considered reasonable and necessary when:

• Arterial endovascular or another invasive arterial revascularization or repair is planned; OR

• Following an endovascular intervention for monitoring complications; OR

• Surveillance in adherence with evidence-based, specialty society guidelines 1-5

DUS of the upper and lower extremity arteries performed to establish the level and/or degree of arterial occlusive disease, will be considered reasonable and necessary if a) significant signs and/or symptoms indicate a high likelihood of limb ischemia, and b) the patient is a candidate for invasive therapeutic procedures under any of the following circumstances:

• Tissue loss resulting from gangrene or pre-gangrenous changes of the extremity, or ischemic ulceration of the extremity occurring in the absence of pulses. 1,6

• Symptoms of peripheral vascular ischemia and absence or marked diminution of pulses (suspected to be secondary to obstruction of lower extremity arteries) of one or both extremities are found on physical examination. 2

• Sudden pallor, numbness, and coolness of an extremity and vascular obstruction (embolism or thrombosis) is suspected. 2,7

• Suspected arterial occlusive disease or stenoses with symptoms including claudication, rest pain, ischemic tissue loss, aneurysm, and/or arterial embolization. 2-4,8

• Claudication is defined by reproducible fatigue, cramping, aching, pain, or other discomfort of vascular origin in a defined group of muscles of the lower extremities (or sometimes arms) that is consistently induced by walking or provoked during objective testing and consistently relieved by rest. 2

• Rest pain of ischemic origin (typically including the forefoot), associated with absent pulses, which becomes increasingly severe with elevation and diminishes with placement of the leg in a dependent position.

• Evaluation of grafts or other vascular intervention when signs and symptoms of ischemia, rejection, and/or vascular disease are present. 2-5

• The monitoring of sites of previous surgical interventions, including sites of previous bypass surgery with either synthetic or autologous grafts. 2-5

• The monitoring of sites of various percutaneous interventions, including angioplasty, thrombolysis/thrombectomy, atherectomy, or stent placement. 2,4,5

• Follow-up surveillance for progression of previously identified disease, such as documented stenosis in an artery that has not undergone intervention, aneurysms, atherosclerosis, or other occlusive diseases when signs and/or symptoms of worsening disease are present. 2-4

• The evaluation of suspected vascular and perivascular abnormalities, including masses, aneurysms, pseudoaneurysms, arterial dissections, vascular injuries, arteriovenous fistulae, thromboses, emboli, or vascular malformations. 2,4,5

• Mapping of arteries prior to surgical interventions. 2,3,8

• Clarifying or confirming the presence of significant arterial abnormalities identified by other imaging modalities in the setting of signs or symptoms of arterial occlusion or stenosis or during the planning for surgical intervention. 2,9

• Evaluation of arterial integrity in the setting of blunt or penetrating trauma with suspicion of vascular injury (including complications of diagnostic and/or therapeutic procedures). 10

• Follow-up studies post-operative conditions: 2-5,11,12

• In the immediate post-operative period, if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.

• Following bypass surgery or post-angioplasty with or without stent placement, exams at 1 month, 3 months, 6 months, and 12 months with a maximum of 4 studies in the initial post-operative year.

• Monitoring for complications following arterial surgical or endovascular procedures: 2-5

• Clinical evidence of recurrent vascular disease evidenced by signs (e.g., decreased ABI from previous exam) or symptoms (e.g., recurrence of claudication symptoms that interfere significantly with the patient’s occupation or lifestyle).

Limitations

The following are not reasonable and necessary:

• Continuous burning of the feet as it is considered to be a neurologic symptom.

• Nonspecific leg pain and pain in a limb as a single diagnosis, unless they are related to other signs and symptoms of arterial vascular disease. 2,3,5

• Generalized or localized edema in the absence of clinically significant symptoms suggestive of arterial dysfunction, abnormal vascular exam, and/or abnormal physiologic testing. 2,3,5

• The absence of peripheral pulses (e.g., dorsalis pedis or posterior tibial) alone is not sufficient to validate arterial DUS imaging as reasonable and necessary. Imaging must only be performed when absent pulses are accompanied by other signs or symptoms indicating clinically significant arterial occlusive disease as well as documented intent to intervene. 2,3,5,8

• DUS imaging of the extremities screening of an asymptomatic patient. 2,3,5,8

• Subsequent studies following post-operative intervention greater in frequency than defined by published guidelines for asymptomatic patients when stable disease has been established .2-5

• The use of a simple hand-held doppler device that does not produce a hard copy or that produces a record that does not permit analysis of bidirectional vascular flow. 13

• The routine performance of multiple duplex scans (e.g., bilateral upper and lower extremities) or multiple scans of the same limb (i.e., venous and arterial imaging) on the same day or within a short time interval is not reasonable and necessary. Venous and arterial conditions typically present with distinct symptoms and diagnostic pathways, such that simultaneous testing is rarely necessary. In rare and clinically appropriate circumstances, multiple studies may be necessary when they:

• Investigate signs or symptoms of arterial occlusive disease reported in multiple limbs with the intent to intervene.

• Address distinct pathologies (e.g., suspected combined arterial and venous disease, or graft surveillance).

• Follow published, evidence-based indications linked to specific clinical scenarios.

In such cases, providers must include an attestation upon claim submission indicating that the services meet all coverage criteria outlined in the relevant coverage policies. Instructions for completing provider attestation are specified in the related billing and coding article (see Related Local Coverage Documents subsection of Associated Documents for article link). Documentation must clearly indicate the clinical rationale for performing all studies and how the results are being used to guide patient care, validating that the circumstances are reasonable and necessary. 2,14

Provider Qualifications

The accuracy of non-invasive arterial diagnostic studies depends on the knowledge, skill and experience of the technologist and the physician or qualified health provider performing the interpretation of the study. 15 Consequently, the technologist or rendering qualified health provider must maintain proof of training and experience.

Services will be considered reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.

For the service to be considered reasonable and necessary, an arterial diagnostic study may be performed by a physician or a technologist when the following qualifications are met. 15

• Performed by a licensed qualified physician as defined by:

• Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty in ultrasound (US); or

• Must reflect equivalent education, training, and expertise endorsed by an academic institution in ultrasound or by applicable specialty/subspecialty society in ultrasound; or

• Has received a minimum of one of the following certifications from the respective accredited credentialing agency:

• American Registry of Diagnostic Medical Sonographers (ARDMS) —Registered Vascular Technologist (RVT); and/or

• Alliance for Physician Certification and Advancement (APCA)—Registered Physician in Vascular Interpretation (RPVI); and/or

• Is able to provide evidence of proficiency in the performance and interpretation of each type of diagnostic procedure performed.

• Performed under the general supervision of a licensed qualified physician by a technologist who has demonstrated minimum entry level competency by being credentialed in vascular technology by an appropriate national credentialing body. The acceptable agencies and certifications for non-physician personnel are as follows:

• American Registry of Diagnostic Medical Sonographers (ARDMS)—Registered Vascular Technologist (RVT); and/or

• Cardiovascular Credentialing International (CCI)—Registered Vascular Specialist (RVS).

• Performed in facilities with laboratories accredited in vascular technology by one of the following agencies:

• Intersocietal Accreditation Commission (ICA), or

• American College of Radiology (ACR)

Please see CMS IOM Publication 100-02, Medicare Benefit Policy Manual , Chapter 15, Section 80, for further detailed supervision definitions and requirements for diagnostic tests.

Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for reasonable and necessary services as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Documentation may be subject to review and must be made available upon request to ensure compliance. Compliance with the provisions in this LCD may be monitored and addressed through post-payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Arterial DUS is a safe and non-invasive imaging study that employs traditional ultrasound technology to identify vascular structures and characteristics, and high-frequency sound waves, to examine blood flow and velocity within the arteries. The term duplex refers to using two ultrasound modes concurrently: B-mode, which provides a 2-dimensional greyscale ultrasound image of the tissues; and doppler, which provides a color flow image depicting blood movement. Arterial duplex ultrasound (which incorporates B‑mode and Doppler assessment) and physiologic studies, are diagnostic modalities used to investigate clinical findings indicative of suspected arterial dysfunction, arterial occlusion, and/or arterial aneurysms. Commonly assessed anatomy with duplex ultrasonography are the arteries of the neck, abdomen, and upper and lower extremities.

Non-invasive physiologic studies are functional measurement procedures including ABI measurement, blood pressure (BP) and physiologic waveforms, doppler ultrasound, segmental pressure measurements, BP measurements, transcutaneous oxygen tension measurements, exercise testing, provocative functional maneuver testing, and/or plethysmography. The physiologic testing is intended to examine bilateral upper or lower extremities at one or more levels. In some cases, unilateral testing can be performed.

The ABI test compares the BP measured at the ankle with the BP measured at the arm (brachial) using a doppler stethoscope and BP cuff.